At the start of this year, the FDA shut off the use of medically important antibiotics to speed up weight gain in cattle, hogs and poultry as part of a government-wide drive to maintain the efficacy of antimicrobials in treating disease in humans. The Government Accountability Office says, “[O]versight gaps still exist” that could allow long-term use of medicine in the name of disease prevention, weakening the limitations on the drugs.
“Without developing a process to establish appropriate durations of use on labels of all medically important antibiotics, FDA will not know whether it is ensuring judicious use of medically important antibiotics in food animals,” said the GAO, a congressional agency, in a report to five Democratic lawmakers interested in the issue.
The lawmakers — Sens. Kirsten Gillibrand of New York State, Dianne Feinstein of California, and Elizabeth Warren of Massachusetts, and Reps. Rosa DeLauro of Connecticut and Louise Slaughter of New York State —asked Health Secretary Tom Price in a letter, “[H]ow will the Food and Drug Administration ensure these antibiotics are used judiciously and not for growth promotion?”
The FDA initiated a three-year phase-out in 2013 of use of important antibiotics for growth promotion. Under the format the took effect in January, the drugs are dispensed under guidance of a veterinarian for treatment or prevention of disease. From the start, activists said the allowance for disease prevention could be used by the livestock industry to obtain growth promotion under another name.
Drugmakers have revised labels to delete growth promotion as a use of medically important antibiotics. The GAO said some labels “do not define duration of use” so there is the possibility of “long-term and open-ended use of antibiotics for disease prevention.”
FDA said it was seeking public comment on how long the antibiotics should be available for disease prevention, “but FDA has not clearly defined objectives for closing this gap, which is inconsistent with federal internal control standards,” said GAO.
The watchdog agency said it “continues to believe [FDA] and USDA need to implement a joint on-farm data collection plan, as previously recommended.”
The CDC estimates that antibiotic-resistant bacteria cause at least 2 million cases of human illness and 23,000 deaths annually in the United States. The health agency says there is strong evidence that some antibiotic resistance is the result of antibiotic use in food animals. The livestock industry disputes that conclusion.
To read a FERN story by Maryn McKenna on the FDA controls on antibiotics in livestock, click here.